Ординатура / Офтальмология / Английские материалы / Eye Banking_Bredehorn-Mayr, Duncker, Armitage_2009

procedures which are well known – on retrospective evaluation of clinical results relating to tissues furnished by the bank.

Procedures must be documented in the SOPs and must guarantee that all the processes are carried out in conformity with the approved SOPs.

Before each significant processing modification, the modified process must be ratified and documented.

The processing procedures must periodically be subjected to critical analysis in order to assure that they continue to attain the intended results.

Procedures to discard tissues must prevent the contamination of other tissues, the working environment and staff. Such procedures must follow national regulations.

Storage and Declaration of Tissue Suitability

A maximum duration must be specified for each type of storage condition. The time chosen must take account of the probable deterioration of the characteristics of the tissues.

A control system is needed to guarantee that tissues are not declared suitable before all the selection procedures have been respected: the bank must thus equip itself with a SOP which specifies the circumstances, the responsibilities and the procedures applicable to the release of tissues for distribution.

The system for the identification of tissues in every phase of processing must clearly differentiate between those in quarantine and those discarded. Records must show that all the corresponding conditions have been observed prior to tissue release: in particular that all the declaration forms in use, the relevant medical records, the processing records and the testing results have been verified according to a written procedure by an operator authorised for this purpose by the person in charge of the bank. If a telematic system is used to communicate laboratory testing results, a control trace must indicate the person responsible for declaring tissue suitability.

It is necessary to undertake a documented estimation of the risks, approved by the person in charge of the bank, to decide the fate of all stored tissues after the introduction of new criteria for the selection or screening of donors or notable modifications to the processing phases, with the object of reinforcing safety and/or quality.

Distribution and Recall

The bank is required to define the critical conditions for tissue transport, such as temperature and expiry date, in order to maintain the requested properties of the tissues.

The container/packaging must be secure and guarantee the preservation of the tissues in the conditions specified. All the containers and packaging must be ratified as suitable for the purpose.

If the distribution is entrusted to a third party, it in necessary to have a documented agreement which guarantees the maintenance of the requested conditions.

In addition, there is a need to have an effective recall procedure, which should include a description of the responsibilities and the actions to undertake, including the notification of the competent authorities. Actions must be embarked upon within a predefined period, provide for the traceability of the tissues concerned and, if required, include a reconstruction of events. Investigations should aim to identify each donor who may have contributed to or caused a reaction in a recipient, to recuperate the tissues originating from such a donor and to inform recipients (or intended recipients) of tissues retrieved from that donor of the potential risk to which they could be exposed to.

The bank must prepare in advance procedures for the handling of tissue requests. Procedures for the allocation of tissues to determined patients or transplantation centres must be documented and communicated at their request.

It is also necessary to have a documented system for the handling of returned tissues, comprising, if need be, the criteria for their entry in the register.

Equipment and Materials

The planning and maintenance of all the equipment and materials must correspond to their expected purposes and minimise every risk for the potential recipients and/ or staff.

All the equipment and critical technical apparatus must be identified and ratified, periodically inspected and subjected to preventive maintenance in compliance with the manufacturer’s instructions. The equipment or materials which affect critical parameters of processing or storage (for example temperature, pressure, particle counts and levels of microbial contamination) must be identified and if necessary subjected to examination, supervision, alarms and suitable corrective interventions to determine any dysfunctions and defects in order to guarantee that the critical parameters constantly remain below the acceptable limits. All the equipment that has a critical measuring function must be calibrated according to an available reference standard, if one exists.

New or repaired equipment must be checked at the moment of installation and validated prior to use. The results of the controls must be documented.

Procedures must allow for the periodic maintenance, cleaning and disinfection of all the critical equipment and the resulting registration of such activities.

The operating norms for each piece of critical apparatus must be clearly displayed, with detailed instructions of how to intervene in case of malfunction or breakdown.

The standards for the activity in which accreditation/designation/authorisation/ licensing is sought must indicate in detail the specifications of all the critical materials and reagents. In particular the analytical descriptions for the additions (e.g. solutions)

and the packaging materials must be defined. The reagents and critical materials must correspond to the legal regulations and to documented provisions and, if applicable, to the prescriptions of European Directive 93/42/CEE of 14 June 1993 [4] concerning medical devices and Directive 98/79/EC [5] of the European Parliament and of the Council of 27 October 1998 regarding in vitro diagnostic medical devices.

Monitoring and Measuring

Measurements, Analyses and Improvement

The bank should have, within the scope of their QMS, plans and actual processes for monitoring, measuring, analysing and introducing improvements necessary to:

•demonstrate conformity of the services delivered and assistance given;

•assure the consistency of the QMS;

•develop in a continuous fashion the efficiency of the QMS.

The bank should establish a feedback system specifically designed to monitor

information regarding:

•its capacity to identify the needs of its clients and the supply of services which it is capable of satisfying;

•the perception of its clients on how far the organisation has satisfied the deter-

mined and expected requisites.

For an analysis of client satisfaction, prepared suitable evaluation questionnaires are administered to patients and collaborating transplant surgeons. The returned data are analysed and converted into statistical form in order to reveal the level of satisfaction, as perceived by the interested parties, and to define any targeted action, if any, required to improve the quality of the delivered services and assistance offered. The results of this analysis should be discussed and examined.

Internal Audits

The procedure for the QMS must define the manner in which internal audits are managed for the purpose of verifying the efficiency and the coherence of the eye bank’s QMS.

The procedure should set out:

•the criteria, extent and periodicity of the controls;

•the tasks and requisites for planning the inspections;

•the responsibilities and modalities for documenting the results of the internal audits and the conservation of the relating records;

•the responsibility for those actions necessary to eradicate the exposed non-compli- ances and their causes.

The audits should:

•be planned and systematic in accordance with the cadence of the agreed programme;

•be carried out in conformity with operative instructions based on written procedures;

•be conducted on the basis of a list of predefined controls (checklist);

•give rise to facts (or data) by which a judgement can be made, based on objective evidence;

•take into consideration the conformity to the procedures, the regulations, the instructions and specifications that constitute the regulative and realised structure of the audited QMS;

•document the results.

The audits must be conducted by persons who are independent from those who

have direct responsibility for the activity undergoing the audit.

Monitoring and Measuring of the Processes

The QMS must adopt adequate methods to monitor and measure the processes, in order to verify the capacity of the processes to obtain the planned results. If such results are not attained, corrections must be adopted and corrective actions undertaken to assure conformity of the services.

The indicators of measure are fixed for the primary processes and data discussed during the review by the management.

Monitoring and Measuring of the Services

The QMS must adopt adequate methods to monitor and measure the performance of the services delivered and to verify that the relative requisites have been satisfied. The monitoring and measurement activities should also be carried out in all the subprocesses.

Evidence of the conformity to the approved criteria should be documented in the appropriate records. These should also indicate the person(s) who is authorised to issue/release a product or service. The release of a product and delivery of a service must not be carried out prior to the successful completion of the foreseen controls.

Management of Non-Conformities

The management of the non-conformities should set out the ways to handle all noncompliances revealed by or to the eye bank staff during the execution of their activities so as to guarantee that:

•those performances and processes that do not conform are identified, managed, recorded and kept under control, with particular reference to adverse reactions or events correlated with the use of tissues revealed as a result of process reviews or communications from transplantation centres;

•services or process results that do not comply with the relevant requirements are identified and kept under control to avoid their involuntary use or dispatch, or used as a consequence of particular situations or according to precise conditions;

•those elements of the quality system that do not conform are promptly pointed out so that they can be brought back to a level of acceptability.

The person in charge of the bank must establish the necessary operative proce-

dures to adopt appropriate preventive or corrective actions with respect to actual or probable effects consequential to potential or ascertained non-compliances of the processes or services delivered.

Data Analysis

The eye bank analyses data for the purpose of obtaining information with regard to:

•client satisfaction;

•conformity to the service requirements;

•the features of the progress/advancement of the processes and services;

•the performance of the suppliers.

Statistical reports containing data and information relative to the activities under-

taken should be elaborated on a periodic basis. Such reports should be distributed to all delegated personnel and discussed during the course of internal informative meetings.

Continuous Improvement

The bank continuously ameliorates the efficiency of the quality system, using the results from the survey of client satisfaction and data that emerges from the statistical reports.

Improvements to the system should be decided during the management review phase and the period for executing and ratifying the efficiency established.

Corrective Actions

Corrective actions are defined as ‘actions undertaken to eliminate the causes of a non-conformity, defects in existence or other undesirable situations, in order to avoid them being repeated’.

They are considered as being fundamental instruments to act upon the causes of the non-conformities with a view to avoiding that these become repetitive.

The activation of a corrective action can be requested as a consequence of a submitted report and/or communication from an informative source, such as:

•non compliance reports;

•reclaims;

•audit reports.

It is important to point out that corrective actions are not intended to correct a non-conformity (in which case one talks of a correction or handling of the non-con- formity), but rather to intervene in the cause which has generated the non-confor- mity, so as to avoid a repetition of the same.

Following the revelation of a non-conformity, the relevant causes must be analysed and a decision made by the person in charge of the bank as to whether a corrective action needs to be embarked upon. In the event that it is considered necessary, the opening of a corrective action must be made on the appropriate form, and the time needed to carry out the corrective action, the person responsible and actions to perform clearly articulated.

Periodically the person in charge of the bank and the quality manager must verify the effectiveness of the corrective actions put into practice.

Preventive Actions

Preventive actions are defined as ‘actions taken to eliminate the causes of potential non-conformities or other potential undesirable situations’.

The sources for the activation of a preventive action are represented in general by:

•audit reports;

•results arising from an analysis of statistical data;

•results from a monitoring of the process indicators;

•modifications to the legislative reference framework;

•analysis of client satisfaction;

•benchmarking.

Every preventive action is characterised by a life cycle which is articulated in the following phases:

•identification of the potential non-conformity and/or area of improvement;

•determination of the possible causes of the non-conformity;

•determination of the necessary preventive actions;

•putting into practice the preventive actions;

•registration of the results of the actions undertaken;

•re-examination of the adopted preventive actions (verifying the effectiveness of the actions adopted).

A preventive action can be defined from whatever organisational position that may involve an area of potential non-conformity and/or improvement. Preventive actions should be discussed and reviewed by the management for verification of their execution and effectiveness.

Mauro Toniolo

Quality Manager

Fondazione Banca degli Occhi del Veneto – ONLUS Via Paccagnella n. 11 – Padiglione Rama

IT–30174 Zelarino – Venice (Italy)

Tel. +39 041 9656446, Fax +39 041 9656401, E-Mail mauro.toniolo@fbov.it

clinical and ethical norms, without any other (financial) considerations. Moreover, these rules should be equitable, externally justified, transparent and defined by constituted bodies consisting of experts in the field of medicine, bioethics and public health (guiding principle 9) [2]. Depending on the healthcare structure and the volume of patients, these allocation rules can be applied on local, regional and/or (inter) national levels.

Allocation Principles

Several criteria can be used to prioritize the patients who are in need of a cornea transplant. In general, the principles for allocation should be based on medical indication, urgency and prospects of success. Unethical aspects such as gender, race and financial capacity of the recipient or surgical center must be rejected as factor of importance in the ranking of patients [3].

The following aspects could be eligible as principles for allocation of corneas.

Medical Aspects

–Underlying cornea disease (factors like pain, rapid progression, prognosis without transplant)

–Chance of graft rejection (previous rejections, immunological risk factors)

–Clinical urgency to save the function of the eye (e.g. perforation)

–Correspondence between donor and recipient age

Social Aspects

–Time spent on the waiting list

–National or regional balance between number of donations and transplantations

–Ability to cope with visual dysfunction

–Social consequences of blindness

Which criteria should be taken into account and with what weight factor, will be

determined by the local balance in demand and supply and the importance that society attaches to the above-mentioned medical and social aspects. The purpose of an allocation algorithm is to provide a society-based and fair division of the available corneas, to safeguard the equal access of patients to donated corneas and to guarantee that patients are treated in the order of their medical urgency (provided that transplantation improves their condition). Special care should be given to the availability of corneas for patients who are in urgent need of a transplant (<5 days) to safeguard the function of the eye.

Table 1. Country of origin of donors and recipients of corneas allocated through BIS Foundation in the period from January 1, 2002, to December 31, 2007

The Organization of Cornea Allocation in the Netherlands in an International Context

In the Netherlands a national system of cornea donation and allocation exists. Potential cornea donors are reported to a central call center, which is operated by BIS Foundation. After initial medical screening, BIS Foundation organizes the procurement and transportation of the bulbi to the cornea banks. The cornea bank assesses the quality of the corneas and reports this information back to BIS Foundation. BIS Foundation keeps a constant overview of the available corneas.

In the meantime, Dutch patients in need of corneas are reported to BIS Foundation and registered on a waiting list. To optimize demand and supply, patients from other European countries are registered on the waiting list as well. Moreover, BIS Foundation collaborates with several cornea banks in Europe to be able to supply to all the patients on the waiting list. By means of this network the pool of (potentially) available corneas can be enlarged, which will improve the chance of patients to receive the most suitable cornea (like for HLA-matched corneas) or meet temporal discrepancies in local demand and supply. Table 1 shows the international exchange of corneas. Over the period 2002–2007, 8,431 corneas were exchanged through this network of international collaboration. Of these, 55% (n = 4,661) was allocated to Dutch patients. The remaining 45% (n = 3,770) was distributed to patients from 8 different European countries and 3 countries outside Europe. The majority (65%)